Sr. Vendor Auditor (Auditor IIICompliance Manager)

Work Schedule

Environmental Conditions

Job Description

Join us as a Sr. Auditor (Auditor III/ Compliance Manager) on the Vendor and Information System Audits Team and make an Impact at the Forefront of Innovation!

Position overview:

The Sr. Auditor is responsible for conducting complex external (vendor) GxP audits to ensure compliance with established quality assurance processes standards global regulatory guidelines (e.g. EMA MHRA FDA) and client contractual obligations.

The Sr. Auditor also identifies issues impacting the quality and/or integrity of clinical research programs determining adequacy of the root cause of non-conformance and the actions to address issues.

What Youll Do:

• Lead and report a variety of GMP GLP and GCP qualification and routine vendor audits as requested by senior management including but not limited to on-site virtual and remote audits of service providers used in clinical trials with or without technology components

• Perform directed vendor audits

• Provide GxP and QA consultation and support to internal and external clients

• Prepare and present audit findings and/or other related information at departmental internal operations or client meetings

• Mentor junior staff.

• Lead process/quality improvement initiatives.

• Develop tools and other materials for tracking of compliance management activities and analyze trends.

Required Education & Experience:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification

• Previous QA and GxP vendor auditing experience that provides the knowledge skills and abilities to perform the job (comparable to 8 years).

• Fluency in English

Required Knowledge Skills & Abilities:

• Solid knowledge of the clinical trial process

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines

• Demonstrated proficiency leading a wide range of GxP vendor audits to high standards

• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)

• Proven training/mentoring experience of staff

• Strong attention to detail

• Effectively works independently or in a team environment

• Highly developed problem solving risk assessment and impact analysis abilities

• Solid experience in root cause analysis and CAPA development

• Expert knowledge of procedural document development

• Strong negotiation and conflict management skills

• Proven adaptability

• Strong organizational and time management skills including flexibility and ability to multi-task and prioritize competing demands/workload

• Strong computer skills; ability to learn and become proficient in appropriate systems

• Valid drivers license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

The following is a plus:

• Experience performing other types of QA audits or activities (e.g. investigator site audits process audits database audits clinical study report audits process improvement)

• Experience hosting client audits and/or regulatory inspections.

Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs!